Memorandum submitted by the Foundation
for Innovative New Diagnostics
ENGAGING THE DIAGNOSTIC INDUSTRY IN DEVELOPMENT:
EXPERIENCES FROM THE FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS
(FIND)
BACKGROUND
New technologies have revolutionized the simplicity,
speed, and accuracy of diagnostics for diseases in the developed
world. The developing world is yet to benefit from this technological
revolution. A mechanism that can link industry to the diagnostic
needs of patients and healthcare providers in developing countries
is needed. The Foundation for Innovative New Diagnostics (FIND)
provides this bridge, enabling industry to engage in the development
and evaluation of new diagnostics for poverty related diseases
through a public-private partnership arrangement.
FIND is a product development, public/private
partnership established by the World Health Assembly in 2003 as
non-profit foundation. FIND is based in Geneva, Switzerland. Its
mission is to develop, evaluate, and facilitate the deployment
of simple, accurate, and affordable point-of-care diagnostic tests
for poverty-related diseases into national disease control programs.
To achieve this mission, FIND:
(1) Chooses technical approaches with performance
characteristics that can maximize benefits to underprivileged
populations.
(2) Builds partnership with key stakeholders—industry,
national disease control programs and diagnostic research facilities
in endemic countries, the World Health Organization, donors, academia,
and civil society.
(3) Pursues intellectual property (IP) strategies
that will result in the greatest accessibility of its inventions
in high endemic countries.
NATURE OF
THE BRIDGE
FIND provides a bridge between industry and
public health needs of developing countries by defining and providing
to the industry partners specifications suitable for patients
and care providers in developing countries; facilitating access
by industry to well characterized and standardized clinical materials
and specimens for validation of new tests; providing access and
logistical support for field evaluation of new tools through a
network of laboratories in developing countries; introducing tests
that have passed the evaluation phase into selected national disease
control programs of the developing countries to demonstrate impact
and usefulness of the tests in a real life situation; assuring
protection of intellectual property rights; and financing the
evaluation and demonstration studies. In pursuing this, FIND keeps
in focus its goal of creating common technological approaches
for diagnosis of several poverty related diseases, and strengthening
the public health systems.
FIND currently collaborates with a number of
leading diagnostic manufacturers, small biotechnology companies,
academia, and public institutions to develop new diagnostic tests,
and recently completed the evaluation of a simplified test to
detect multidrug-resistant tuberculosis. This collaboration with
Biotec Ltd., a UK company, has resulted in the development of
a breakthrough diagnostic test which gives results within two
days rather than the many weeks it takes to diagnose multidrug-resistant
tuberculosis using existing tests. For more information on FIND's
tuberculosis portfolio, please visit www.finddiagnostics.org
Collaborating with industry and academic researchers
enables FIND to advance promising reagents and platforms, for
which there exists proof of principle, into optimized diagnostic
products. FIND contracts and provides funds to public health laboratories
to evaluate the performance characteristics of market-ready tests
in regulatory-quality laboratory and field trials. Through collaboration
with public health authorities FIND is able to demonstrate the
feasibility and programmatic impact on patients and control programs
of new tests and thus generate objective evidence for the broader
uptake of new diagnostic tests in the public health sector.
PROTECTING BOTH
INDUSTRY AND
PATIENTS' INTERESTS
In all of FIND's contractual agreements with
industry partners, methods are clearly defined to ensure that
each dollar invested by FIND results in a return for the public
sector in the form of affordability and access. This is achieved
in a variety of ways, depending on the nature of the project,
maturity of the technology, size of the company, and size of FIND's
total investment. When there is significant intellectual property
(IP) involved, FIND typically seeks an irrevocable, royalty free
license to the IP for the public sector in developing countries.
Where necessary, FIND may purchase the IP outright to ensure access.
In other cases, when IP is either irrelevant or not negotiable,
negotiated product pricing may be the primary mechanism to ensure
affordability and access.
On the question of predictable supply of quality
assured diagnostic tools, FIND's strategy of involving both WHO
and industry in the development, evaluation and demonstration
phase of selected tools ensures that well-performing tools are
readily manufactured in a quality-assured manner. FIND is also
exploring innovative mechanisms for ensuring that the tools introduced
into national policy do indeed reach populations that access health
care through both the public and private health sectors and at
all levels of the health systems, including the most peripheral
point of care facilities.
DONOR PARTNERS
The original project, funded by Bill and Melinda
Gates Foundation, targets the development and evaluation of improved
tuberculosis diagnostic tests. Tuberculosis, which claims two
million lives a year, is now compounded by co-infection with HIV/AIDS.
Around 95% of new tuberculosis cases each year originate in the
developing world where diagnosis still relies on time-consuming
and frequently inaccurate microscopy developed over a century
ago. Bill and Melinda Foundation is also financing FIND's recently
launched program to develop better point-of-care tests for diagnosis
of human African trypanosomiasis (HAT), or sleeping sickness,
one of the world's most neglected public health problem, with
an estimated 50 million people at risk.
With additional resources currently being sought
from DFID and other donors, FIND will be able to expand its portfolio
to include malaria and other neglected diseases since common diagnostic
platforms can be used to develop new tools. In many regions of
the world most malaria episodes are misdiagnosed. Treating every
fever as malaria is wasteful of resources, and is costly to children,
as other common causes of fever in children, such as bacterial
meningitis, urinary tract infections and pneumonia may be overlooked
with disastrous health consequences.
FIND'S BUSINESS
MODEL
FIND conducts its business in a start-up venture
mode. For each disease, both existing and new diagnostic tools
with characteristics convergent with FIND's mission and strategy
are recruited into evaluation in high-quality clinical trials
for registration purposes and in large-scale demonstration projects
to provide information on cost, ease of use and public health
impact. Each project portfolio is managed in a business unit with
product lines and defined targets and timing at each stage of
the R&D process, from development, through evaluation and
demonstration of impact of well-performing technologies, to policy
implementation. All the critical steps of the business model are
subject to policy analysis to assure conformity to FIND's mission.
Vinand M Nantulya
May 2006
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